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Trial · Interventional

Enrolling by invitationPhase 4Registry data

Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors

Short name RCT-PIDST

NCTNCT07712328 (opens ClinicalTrials.gov in a new tab)Other idKY2026-753
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Enrolling by invitation
Phase
Phase 4
Enrollment
152 participants (estimated)
Sponsor
Zhaoyun Zhang · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
2 Jun 2026
Primary completion
1 May 2028 (estimated)
Completion
1 Sept 2028 (estimated)
First posted
17 Jul 2026
Last update posted
17 Jul 2026
Conditions
Craniopharyngiomas · Pituitary Macroadenoma · Sellar and Suprasellar Masses

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 4

    RCT-PIDST

    NCT07712328

    2 Jun 2026 to est. 1 Sept 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Craniopharyngiomas and giant invasive pituitary adenomas, with lesions originating from the pituitary stalk, are frequently associated with intraoperative and postoperative diabetes insipidus (DI). DI can lead to hypernatremia, and the rapid elevation of serum sodium within hours can precipitate acute brain tissue shrinkage, potentially resulting in devastating complications including intracerebral hemorrhage, cerebral venous sinus thrombosis, seizures, somnolence, and coma. Furthermore, dehydration secondary to DI may compromise organ perfusion and enhance anaerobic glycolysis in tissues, leading to hyperlactatemia and even lactic acidosis. However, the currently available evidence is insufficient to support the routine prophylactic anti-diuretic therapy during surgery.This study aims to evaluate the efficacy and safety of prophylactic low-dose continuous intravenous dDAVP infusion in patients undergoing surgery for complex sellar region lesions, with respect to reducing the incidence of hypernatremia occurring during surgery or within the first 24 hours postoperatively.

Interventions

  • Desmopressin (DDAVP)Drug
  • ControlOther

Arms2

  • Experimental

    Intervention group

    Receiving prophylactic dDAVP treatment during surgery

  • Placebo comparator

    Control group

    Not receiving prophylactic dDAVP treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of hypernatremia within the first 24 hours postoperatively

    Time frame · Up to 24 hours postoperatively

    Registry description

    Incidence of hypernatremia (serum sodium \> 145 mmol/L) or use of rescue therapy for hypernatremia within the first 24 hours postoperatively

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultDavoudi Z, Shahriari S, Rezaei O, Amirdosara M, Vakili K, Zangi M, Samadian M, Haghighimorad M, Ebrahimzade K, Mousavinejad SA, Sayehmiri F, Hallajnejad M, Sharifi G. Incidence and risk factors for transient and permanent central diabetes insipidus following pituitary adenoma surgery: a single center study. Int J Neurosci. 2026 Apr;136(4):417-425. doi: 10.1080/00207454.2025.2564646. Epub 2025 Nov 12. PMID 41221987
  • ResultYu Z, Swenson K, Graber E. Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne. J Clin Aesthet Dermatol. 2025 Jan;18(1):20-23. PMID 39830821
  • ResultSugiura A, Weber M, Tabata N, Goto T, Ozturk C, Lin M, Zimmer S, Nickenig G, Sinning JM. QRS duration is a risk indicator of adverse outcomes after MitraClip. Catheter Cardiovasc Interv. 2021 Oct;98(4):E594-E601. doi: 10.1002/ccd.29505. Epub 2021 Feb 1. PMID 33527610
  • ResultSummers BJ, Wilver NL, Garratt GH, Cougle JR. A Multimethod Analysis of Incompleteness and Visual "Not Just Right" Experiences in Body Dysmorphic Disorder. Behav Ther. 2020 Sep;51(5):764-773. doi: 10.1016/j.beth.2019.11.001. Epub 2019 Nov 26. PMID 32800304
  • ResultHayakawa S, Matsumura H, Nakamura N, Yohda M, Ohno H. Spectroscopic characterization of the acid-alkaline transition of a thermophilic cytochrome P450. FEBS Lett. 2013 Jan 4;587(1):94-7. doi: 10.1016/j.febslet.2012.11.017. Epub 2012 Nov 27. PMID 23195688
  • ResultTakami A. Guest editorial: new basic and clinical aspects of graft-versus-host disease: what can we do without ''Doc'' Brown's help? Int J Hematol. 2013 Sep;98(3):273-4. doi: 10.1007/s12185-013-1417-6. No abstract available. PMID 23959584
  • ResultCodd LN, Blackmore DG, Vukovic J, Bartlett PF. Exercise reverses learning deficits induced by hippocampal injury by promoting neurogenesis. Sci Rep. 2020 Nov 6;10(1):19269. doi: 10.1038/s41598-020-76176-1. PMID 33159114
  • ResultLi X, Chen C, Zhang T, Ding N, Zheng P, Yang M. Comparative pharmacokinetic studies of five C-glycosylflavones in normal and urolithiasis model rats following administration of total flavonoids from Desmodium styracifolium by liquid chromatography-tandem mass spectrometry. J Sep Sci. 2022 Aug;45(15):2901-2913. doi: 10.1002/jssc.202200010. Epub 2022 Jun 25. PMID 35671519
  • ResultTrilok G, Draper HH. Effect of a high protein intake on acid-base balance in adult rats. Calcif Tissue Int. 1989 May;44(5):339-42. doi: 10.1007/BF02556314. PMID 2496905
  • ResultGraham ZA, Harlow L, Bauman WA, Cardozo CP. Alterations in mitochondrial fission, fusion, and mitophagic protein expression in the gastrocnemius of mice after a sciatic nerve transection. Muscle Nerve. 2018 Oct;58(4):592-599. doi: 10.1002/mus.26197. Epub 2018 Sep 3. PMID 30028528
  • ResultMorin-Papunen L, Rautio K, Ruokonen A, Hedberg P, Puukka M, Tapanainen JS. Metformin reduces serum C-reactive protein levels in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Oct;88(10):4649-54. doi: 10.1210/jc.2002-021688. PMID 14557435
  • ResultColares L, Lopes-Neto RB, Siqueira AS, Leao CF, Castro AF, Dunck B. Functional diversity in human song. PLoS One. 2024 Jul 12;19(7):e0307032. doi: 10.1371/journal.pone.0307032. eCollection 2024. PMID 38995891
  • ResultKumrawat A, Gupta S, Dhillon HS, Kumrawat P. Prognostic Value of Admission Lactate Levels in Critically Ill Patients: A Comparative Study With Sequential Organ Failure Assessment and Acute Physiology and Chronic Health Evaluation II Scores. Cureus. 2024 Oct 13;16(10):e71372. doi: 10.7759/cureus.71372. eCollection 2024 Oct. PMID 39539913
  • ResultNovitskaya MG, DeRosa PA, Chen DT, Khalil A, Harfouch O, O'Connor EE, Schmalzle SA. Rapidly Enlarging Parotid Mass in a Person Living with HIV: A Case of Multiple Myeloma with Extramedullary Plasmacytoma. Am J Case Rep. 2023 Aug 3;24:e938431. doi: 10.12659/AJCR.938431. PMID 37533236
  • ResultLipshultz SE, Franco VI, Miller TL, Colan SD, Sallan SE. Cardiovascular disease in adult survivors of childhood cancer. Annu Rev Med. 2015;66:161-76. doi: 10.1146/annurev-med-070213-054849. PMID 25587648
  • ResultEdate S, Albanese A. Management of electrolyte and fluid disorders after brain surgery for pituitary/suprasellar tumours. Horm Res Paediatr. 2015;83(5):293-301. doi: 10.1159/000370065. Epub 2015 Feb 11. PMID 25677941
  • ResultKamel KS, Schreiber M, Harel Z. Hypernatremia. JAMA. 2022 Feb 22;327(8):774-775. doi: 10.1001/jama.2022.1376. No abstract available. PMID 35191944
  • ResultGiraldi EA, Ioachimescu AG. Postoperative Considerations Following Pituitary Surgery: A Guide for Clinicians. Endocr Pract. 2025 Oct;31(10):1339-1345. doi: 10.1016/j.eprac.2025.06.018. Epub 2025 Jun 26. PMID 40581268
  • ResultBurke WT, Cote DJ, Penn DL, Iuliano S, McMillen K, Laws ER. Diabetes Insipidus After Endoscopic Transsphenoidal Surgery. Neurosurgery. 2020 Oct 15;87(5):949-955. doi: 10.1093/neuros/nyaa148. PMID 32503055
  • ResultJoshi RS, Pereira MP, Osorio RC, Oh T, Haddad AF, Pereira KM, Donohue KC, Peeran Z, Sudhir S, Jain S, Beniwal A, Chandra A, Han SJ, Rolston JD, Theodosopoulos PV, Kunwar S, Blevins LS, Aghi MK. Identifying risk factors for postoperative diabetes insipidus in more than 2500 patients undergoing transsphenoidal surgery: a single-institution experience. J Neurosurg. 2022 Jan 28;137(3):647-657. doi: 10.3171/2021.11.JNS211260. Print 2022 Sep 1. PMID 35090129

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * (1) Demographic information: Age 18 to 75 years, any gender, any race. (2) Target disease: Preoperative pituitary MRI-confirmed diagnosis of sellar region lesions requiring surgical intervention, including craniopharyngioma, pituitary adenoma, and other sellar region lesions. The patient must meet at least two of the following high-risk criteria: 1. Preoperatively confirmed central diabetes insipidus (CDI); 2. Maximum tumor diameter \> 3 cm with imaging evidence of suprasellar extension; 3. Imaging evidence of close anatomical relationship with the pituitary stalk, posterior pituitary, or hypothalamus, including compression, encasement, or invasion; 4. Estimated surgical duration \> 4 hours. (3) Health status: Adequate organ function to tolerate surgery, and no contraindications to desmopressin (dDAVP) administration. American Society of Anesthesiologists (ASA) Physical Status classification I, II, or III, with comorbid conditions being stably controlled prior to surgery. (4) Concomitant medication: Patients must have discontinued medications that may significantly affect intraoperative water-electrolyte balance (e.g., thiazide diuretics, antipsychotics such as chlorpromazine, olanzapine, clozapine, carbamazepine, etc.) prior to surgery, until the investigator assesses the risk as acceptable Exclusion Criteria: * (1) Patients with pre-existing comorbidities affecting water and salt metabolism, including but not limited to: 1. Renal insufficiency (dDAVP is predominantly excreted unchanged by the kidneys; renal impairment may significantly prolong its half-life and increase the risk of hyponatremia); 2. Cardiac insufficiency (dDAVP-induced water and sodium retention may increase circulating blood volume and potentially precipitate heart failure); 3. Untreated adrenal insufficiency (cortisol deficiency impairs free water excretion); 4. Uncorrected hyponatremia prior to surgery. (2) Patients requiring concomitant use of medications that may induce hyponatremia and cannot be temporarily discontinued, including but not limited to chlorpromazine, olanzapine, clozapine, carbamazepine, thiazide diuretics, etc. (3) Pregnant or breastfeeding patients. (4) Patients with known hypersensitivity to dDAVP or any of its excipients. (5) Patients currently participating in any other clinical trial. If the patient has previously participated in a drug clinical trial, the time from the last dose of the investigational drug must exceed 4 weeks. (6) Any other conditions deemed unsuitable for participation in this study by the investigator's judgment.

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